Project SERVE: Post Deployment Functioning

NCT ID: NCT01123642

Last Updated: 2018-08-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

345 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Functional recovery is of the utmost importance to evaluate in our returning Operation Enduring and Iraqi Freedom Veterans so that we can better understand their needs and experiences during the readjustment process from warzone to civilian life. Although most soldiers are resilient, concerning rates of PTSD (12-20%) and depression (14-15%) have been found, and as many as 24-35% report drinking more alcohol than they intended (Hoge et al., 2004). The current study proposes to follow returning Veterans for a one-year period to evaluate factors that influence the readjustment process and functional impairment. This information should guide the development of early intervention and treatment programs to help recovery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The proposed longitudinal study aims to better understand the functioning of returning Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) OEF/OIF Veterans over time and to identify potentially malleable resilience factors associated with higher levels of functioning. A total of 300 returning OEF/OIF Veterans will be followed for a one-year period. Veterans will complete a baseline assessment, followed by three follow-up assessments (two self-report assessments mailed at 4- and 8-months post-baseline and a one-year in-person follow-up assessment that repeats many of the baseline clinician-administered assessments). Multiple functional outcomes will be evaluated, including occupational, family, social, and physical functioning. The specific aims include: 1) identifying whether a "dose-response" relationship exists between level of exposure to stressors (pre-deployment, deployment-related, and post-deployment) and functioning over time; 2) examining whether potentially malleable resilience factors predict higher levels of functioning in returning Veterans over time; 3) examining whether psychopathology predicts lower levels of functioning in returning Veterans over time; 4) testing the theoretical model that psychopathology partially mediates the effects of stress, social support, coping, and neurocognition on functioning over time; 5) examining whether changes in the use of healthy coping strategies, social support, post-deployment stress, and psychopathology predict changes in functioning over time; and 6) exploring whether stress, social support, coping, neurocognition, and psychopathology have differential effects on specific aspects of functioning (e.g., occupational, family, social, and physical functioning) over time. The long-term aim of this research is to develop evidence-based early intervention and treatment programs designed to assist returning OEF/OIF Veterans with achieving optimal functioning when reintegrating into civilian life. In keeping with the VHA's goal of operationalizing principles of recovery and rehabilitation in treatment planning, this research should provide a platform of empirical data to assist with the further development of meaningful early intervention and treatment programs to assist OEF/OIF Veterans with the post-war readjustment process over time.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-traumatic Stress Disorder Depressive Disorder Alcoholism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Operation Enduring Freedom and Operation Iraqi Freedom Veterans

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

To be eligible, participants must be:

* enrolled returning OEF/OIF Veteran within CTVHCS;
* English-speaking Veterans;
* able to comprehend and sign the informed consent form;
* able to complete the structured interviews and self-report assessments;
* willing to be contacted for follow-up assessments;
* deemed stable on psychotropic medications and in psychotherapy.

Exclusion Criteria

Veterans will be excluded if they:

* plan to relocate out of the Central Texas area within four months of protocol initiation;
* meet criteria for a diagnoses of schizophrenia, other psychotic disorders, or bipolar disorder;
* report current hallucinations or delusions that are clearly not trauma-related; or
* report current suicidal or homicidal risk warranting crisis intervention.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Texas A&M University

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sandra B Morissette, PhD

Role: PRINCIPAL_INVESTIGATOR

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Waco, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Dolan S, Martindale S, Robinson J, Kimbrel NA, Meyer EC, Kruse MI, Morissette SB, Young KA, Gulliver SB. Neuropsychological sequelae of PTSD and TBI following war deployment among OEF/OIF veterans. Neuropsychol Rev. 2012 Mar;22(1):21-34. doi: 10.1007/s11065-012-9190-5. Epub 2012 Feb 18.

Reference Type BACKGROUND
PMID: 22350690 (View on PubMed)

Konecky B, Meyer EC, Marx BP, Kimbrel NA, Morissette SB. Using the WHODAS 2.0 to assess functional disability associated with DSM-5 mental disorders. Am J Psychiatry. 2014 Aug;171(8):818-20. doi: 10.1176/appi.ajp.2014.14050587. No abstract available.

Reference Type BACKGROUND
PMID: 25082488 (View on PubMed)

Greenawalt DS, Tsan JY, Kimbrel NA, Meyer EC, Kruse MI, Tharp DF, Gulliver SB, Morissette SB. Mental Health Treatment Involvement and Religious Coping among African American, Hispanic, and White Veterans of the Wars of Iraq and Afghanistan. Depress Res Treat. 2011;2011:192186. doi: 10.1155/2011/192186. Epub 2011 Jul 18.

Reference Type RESULT
PMID: 21785719 (View on PubMed)

Morissette SB, Woodward M, Kimbrel NA, Meyer EC, Kruse MI, Dolan S, Gulliver SB. Deployment-related TBI, persistent postconcussive symptoms, PTSD, and depression in OEF/OIF veterans. Rehabil Psychol. 2011 Nov;56(4):340-50. doi: 10.1037/a0025462.

Reference Type RESULT
PMID: 22121940 (View on PubMed)

Debeer BB, Kimbrel NA, Meyer EC, Gulliver SB, Morissette SB. Combined PTSD and depressive symptoms interact with post-deployment social support to predict suicidal ideation in Operation Enduring Freedom and Operation Iraqi Freedom veterans. Psychiatry Res. 2014 May 30;216(3):357-62. doi: 10.1016/j.psychres.2014.02.010. Epub 2014 Feb 17.

Reference Type RESULT
PMID: 24612971 (View on PubMed)

Stock EM, Kimbrel NA, Meyer EC, Copeland LA, Monte R, Zeber JE, Gulliver SB, Morissette SB. A Bayesian model averaging approach to examining changes in quality of life among returning Iraq and Afghanistan veterans. Int J Methods Psychiatr Res. 2014 Sep;23(3):345-58. doi: 10.1002/mpr.1442. Epub 2014 Jun 18.

Reference Type RESULT
PMID: 24942672 (View on PubMed)

Grosso JA, Kimbrel NA, Dolan S, Meyer EC, Kruse MI, Gulliver SB, Morissette SB. A test of whether coping styles moderate the effect of PTSD symptoms on alcohol outcomes. J Trauma Stress. 2014 Aug;27(4):478-82. doi: 10.1002/jts.21943.

Reference Type RESULT
PMID: 25158641 (View on PubMed)

Kimbrel NA, Evans LD, Patel AB, Wilson LC, Meyer EC, Gulliver SB, Morissette SB. The critical warzone experiences (CWE) scale: initial psychometric properties and association with PTSD, anxiety, and depression. Psychiatry Res. 2014 Dec 30;220(3):1118-24. doi: 10.1016/j.psychres.2014.08.053. Epub 2014 Sep 6.

Reference Type RESULT
PMID: 25238984 (View on PubMed)

Kimbrel NA, Morissette SB, Meyer EC, Chrestman R, Jamroz R, Silvia PJ, Beckham JC, Young KA. Effect of the 5-HTTLPR polymorphism on posttraumatic stress disorder, depression, anxiety, and quality of life among Iraq and Afghanistan veterans. Anxiety Stress Coping. 2015;28(4):456-66. doi: 10.1080/10615806.2014.973862. Epub 2014 Nov 14.

Reference Type RESULT
PMID: 25314020 (View on PubMed)

Wilson LC, Kimbrel NA, Meyer EC, Young KA, Morissette SB. Do child abuse and maternal care interact to predict military sexual trauma? J Clin Psychol. 2015 Apr;71(4):378-86. doi: 10.1002/jclp.22143. Epub 2014 Dec 22.

Reference Type RESULT
PMID: 25534500 (View on PubMed)

Kimbrel NA, DeBeer BB, Meyer EC, Silvia PJ, Beckham JC, Young KA, Morissette SB. An examination of the broader effects of warzone experiences on returning Iraq/Afghanistan veterans' psychiatric health. Psychiatry Res. 2015 Mar 30;226(1):78-83. doi: 10.1016/j.psychres.2014.12.007. Epub 2014 Dec 13.

Reference Type RESULT
PMID: 25541538 (View on PubMed)

Hiraoka R, Meyer EC, Kimbrel NA, DeBeer BB, Gulliver SB, Morissette SB. Self-Compassion as a prospective predictor of PTSD symptom severity among trauma-exposed U.S. Iraq and Afghanistan war veterans. J Trauma Stress. 2015 Apr;28(2):127-33. doi: 10.1002/jts.21995. Epub 2015 Mar 21.

Reference Type RESULT
PMID: 25808565 (View on PubMed)

Myers MN, Kurz AS, Paul J, Wild MG, O'Brien SF. Gender differences in reported potentially morally injurious events among post-9/11 U.S. combat veterans, using two measures. Psychol Trauma. 2024 Nov 7. doi: 10.1037/tra0001782. Online ahead of print.

Reference Type DERIVED
PMID: 39509229 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1I01RX000304-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

D7202-R

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Service Dogs for Veterans With PTSD
NCT01329341 TERMINATED NA